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AsAudit
AsAudit
ensures integrated support of users’ authorizations and control of
performed operations. AsAudit module realizes the following
functions:
-
Handling
the database of users and their authorizations, common for all
asix
system modules. Except authorizations available in
asix
v. 4, AsAudit enables protection of access to any file included in
application (that means, among other things, it is possible to block
for the user the right of command calling, in effect, the right to
display specified process screens) and protection of control
operations related to individual process variables. All user log-in
operations and also all events of attempted unauthorized access to
application elements are registered in a database.
-
Application file integrity control. This functionality consists in
verification whether the contents of the vars database and the
application files have been changed in an unauthorized way (i.e.
whether user-made modifications were not confirmed through
registration in AsAudit database). Each event of files modification
is logged in the database.
-
Logging
control operations performed on selected process variables. AsAudit
registers the following data: time of control execution, name of
machine performing the control, ID of the logged-in user, value of
process variable before the control operation and the control value.
-
Logging
the operator’s actions. It is possible to register which masks (screens)
, tables of variables, trends were opened and closed by operator on
the selected asix system stations.
-
System of
entering and registering the user notes (it replaces the Notepad
module available in
asix
v. 4).
Functionality of AsAudit module in the field of application
integrity control and registration of system operation history
enables to realize system validation in accordance with
FDA 21 CFR Part 11
/ GAMP4
regulations, applied in pharmaceutical and food processing industry.
Functions in the range of support of users and their authorizations
as well as registration of user’s notes are available in each
engineering station, operator station, operator server and terminal
license of asix
system at no additional charge.
To use the functions of integrity control, logging the control
operations and logging the operator’s actions, the additional
AsAudit or AsAudit – Lite license need to be bought for the
mentioned above
asix
system licenses. Type of required AsAudit license depends on the
basic asix
system license used as follows:
WDUW local engineering station – no additional AsAudit license is
needed
WDUN network engineering station – AsAudit – Lite license is needed
WATW, WAEW, WALW, WABW operator station– AsAudit – Lite license is
needed
WACW, WAAW, WAUW operator station – AsAudit license is needed
Operator server – AsAudit license is needed
Terminal – AsAudit – Lite license is needed
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